Intraprostatic Botulinum Toxin Type "A" Injection in Patients With Benign Prostatic Hyperplasia and Unsatisfactory Response to Medical Therapy

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

The injection of botulinum neurotoxin A into the prostate represents an alternative, minimal invasive treatment in patient with lower urinary tract symptoms (LUTS) associated to benign prostatic hyperplasia (BPH).

Objective: To evaluate the effectiveness of BTA in treating patients with symptomatic BPH and unsatisfactory response to combined medical therapy.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Catholic University of the Sacred Heart
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Inclusion Criteria:

• Moderate-to-severe LUTS as determined by the International Prostate Symptom Score

• Mean peak urinary flow rate of no more than 15 mL/s with a voided volume of at least 150 mL, or postvoid residual urine volume (PVR) of more than 100 ml and urodynamic parameters indicative of bladder outlet obstruction (BOO) according to International Continence Society

Exclusion Criteria:

• Patients with neurogenic voiding disorders, prostate or bladder cancer, bladder stones, urethral stricture, chronic bladder catheterization were excluded from the study.